Clinical
Trials Administrative Start-Up Handbook
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Clinical
Trials Administrative Start-Up Handbook |
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Purpose of the Handbook
This Handbook was originally developed at the University of Washington School of Medicine in order to ensure that the administrative start-up process for industry-sponsored clinical trials could be accomplished as quickly and efficiently as possible. Over time, the Handbook has evolved to present practical information not only about the start-up process of industry-sponsored clinical trials but also about other practical information relating to clinical research.
We hope that the Handbook will continue to evolve in response to your suggestions and to changing practices. Please provide us with updates, feedback, advice, recommendations, and corrections by calling Gigi Streidl at 206-616-8289 or sending email to restudy@u.washington.edu.
The Handbook is addressed to all study teams who conduct clinical trials at the UW. We hope that the Handbook will be especially useful for new or "occasional" clinical trials researchers. Although experienced study teams may already have developed handbooks of their own, we hope that some parts of this Handbook will also be helpful to them. Note that investigators conducting clinical trials on site at the Veterans Affairs Puget Sound Health Care System (VAPSHCS) may have different or additional requirements for the administrative start-up process and should contact the VAPSHCS Associate Chief of Staff for Research at 206-764-2018.
Throughout the Handbook, there are links to relevant Web sites, forms, and people who can help you with the start-up process. If forms are not available electronically, please call the "Key Contact" person listed in that Handbook section.
Not all of the administrative committees described in the various sections of this Handbook will have oversight responsibilities for every trial, but you will need to determine early in the start-up process which of the committees will need to approve your trial. As appropriate, and if possible, you should submit the necessary paperwork to each of the involved oversight bodies at approximately the same time. Key contact people will be able to advise you about submission timing. By submitting your paperwork concurrently, you can avoid long delays (possibly months).
Contact Gigi Streidl, Clinical Trials Administrative Manager, at 206-616-8289 for assistance and/or for advice about troubleshooting the clinical trial administrative start-up process. When speaking with industry representatives, please refer them to Gigi as the central UW contact for help with siting trials at UW Medicine.
Contact Clinical Research Budget & Billing Support Office (CRBB) at 206-598-9490 for assistance with the budgeting and billing components of your clinical research. CRBB is available to assist research investigators and their staff with creating study budgets, negotiating the budgets with industry sponsors, understanding research billing policies, and navigating the billing process. In short, CRBB staff can provide hands-on assistance and advice about managing the details of clinical research finances, regardless of funding source. When you contact CRBB, be sure to ask about their class schedule. See Section 1 of the Handbook for more information about CRBB classes.